GET TESTED INTERNATIONAL AB recalled 27 units of the PSA Test on November 3, 2025. The recall stems from distribution without premarket approval or clearance. Patients and healthcare providers must stop using the test immediately.
Distribution without premarket approval/clearance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact GET TESTED INTERNATIONAL AB or your healthcare provider for instructions. Notification method: Letter
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The recalled PSA Test has the following identifiers: EAN 616612787316, SKU G670D. It was distributed nationwide in the United States. The exact retail price is unknown.
The PSA Test was distributed without necessary premarket approval or clearance, posing potential risks to patients. This classification is marked as Class II, indicating moderate risk.
No injuries or incidents have been reported in connection with the use of the recalled PSA Test. The recall is precautionary due to the lack of regulatory approval.
Patients and healthcare providers should stop using the PSA Test immediately. Follow the recall instructions provided by GET TESTED INTERNATIONAL AB and contact them or your healthcare provider for further guidance.
For further assistance, contact GET TESTED INTERNATIONAL AB directly. You can also visit their website or the FDA recall page for more information.
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